Volume 37 - August 2007

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Sarasota's Roskamp Institute Releases Study Defining a Mechanism for Development of Obesity and the Metabolic Syndrome, Forerunners of Type 2 Diabetes
Findings Detailed in The Journal of Clinical Investigation SARASOTA, Fla., Aug 1 -- The Roskamp Institute today released a study defining a mechanism for the development of obesity and the metabolic syndrome, which are the forerunners...

Lev Pharmaceuticals Submits Biologics License Application for Cinryze
First company to submit licensing application to the FDA for the acute treatment of HAE NEW YORK, July 31, 2007 -- Lev Pharmaceuticals, Inc. ("Lev") today announced that it has submitted a Biologics License Application...

KV Pharmaceutical Announces U.S. Food and Drug Administration Approval of EvaMist
EvaMist is the First Estradiol Transdermal Spray Approved by the US FDA ST. LOUIS, July 30, 2007 -- KV Pharmaceutical Company today announced that VIVUS, Inc. has received U.S. Food & Drug Administration (FDA) approval for...

D.C. Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not FDA To Blame
CHARLOTTESVILLE, Va., July 30, 2007  -- Many in the prostate cancer community are still outraged over the FDA's decision to deny approval for the immunotherapy drug Provenge. Some have even gone as far as to make threats against...

GPC Biotech Withdraws Satraplatin NDA for Accelerated Approval; Plans to Resubmit With Survival Analysis
IRVINE, Calif., July 30, 2007  -- Spectrum Pharmaceuticals, Inc., today announced that GPC Biotech has withdrawn the satraplatin New Drug Application (NDA) filed for accelerated approval for the treatment of...

Anika Therapeutics Receives FDA Approval for Elevess Product
WOBURN, Mass.--Jul 24, 2007 - Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it has received U.S. FDA approval for commercial sale of its corrective and aesthetic dermatology product. This product is licensed to...

Rotateq and Gardasil Adopted by All Immunization Projects of the Centers for Disease Control and Prevention's Vaccines for Children Program
WHITEHOUSE STATION, N.J.--Jul 16, 2007 - Merck & Co., Inc. announced today that both Rotateq (rotavirus vaccine, live, oral, pentavalent) and Gardasil (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine) have now been adopted by all 55 U.S.-based immunization projects of the Centers for Disease Control and Prevention's (CDC) Vaccines for Children (VFC) program...

Schwarz Pharma and UCB, Inc. Announce U.S. Launch of Neupro (Rotigotine Transdermal System) for the Treatment of Early-Stage Parkinson's Disease
MONHEIM, Germany, July 16, 2007 -- Schwarz Pharma and UCB, Inc. announced today that Neupro ((Rotigotine Transdermal System), a new once-daily transdermal dopamine agonist approved for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease...

Depomed Announces Results of Phase 3 Clinical Trial for Gabapentin GR In Postherpetic Neuralgia
MENLO PARK, Calif.--Jul 10, 2007 - Depomed, Inc. (NASDAQ:DEPO) today announced results from its Phase 3 clinical trial of Gabapentin GR, an investigational extended release tablet for the treatment of patients with postherpetic neuralgia ((PHN). PHN is a persistent neuropathic pain condition caused by nerve damage after a shingles...



Latest Drug Approvals
The following drugs have recently been approved by the FDA.

EvaMist (estradiol) Transdermal Spray
Date of Approval: July 27, 2007
Company: VIVUS, Inc.
Treatment for: Postmenopausal Symptoms

CaloMist (cyanocobalamin) Nasal Spray
Date of Approval: July 27, 2007
Company: Fleming & Company, Pharmaceuticals
Treatment for: Vitamin B12 Deficiency

Privigen (Immune Globulin Intravenous (Human)) 10% Liquid
Date of Approval: July 26, 2007
Company: CSL Behring
Treatment for: Primary Immunodeficiency Syndrome, Idiopathic (Immune) Thrombocytopenic Purpura

Atralin Gel (tretinoin 0.05%) Gel
Date of Approval: July 26, 2007
Company: Coria Laboratories, Ltd.
Treatment for: Acne

Exelon Patch (rivastigmine) Transdermal System
Date of Approval: July 6, 2007
Treatment for: Alzheimer's Disease

Endometrin (progesterone) Vaginal Insert
Date of Approval: June 21, 2007
Treatment for: Female Infertility

Exforge (amlodipine and valsartan) Tablets
Date of Approval: June 20, 2007
Treatment for: Hypertension

Nuvigil (armodafinil) Tablets
Date of Approval: June 15, 2007
Treatment for: Excessive Sleepiness

Letairis (ambrisentan) tablets
Date of Approval: June 15, 2007
Treatment for: Pulmonary Arterial Hypertension

Extina (ketoconazole) Foam
Date of Approval: June 12, 2007
Treatment for: Seborrheic Dermatitis



Latest FDA MedWatch Alerts
MedWatch alerts are concerning pharmaceuticals already released in the USA and are issued by the FDA.

Invanz (ertapenem sodium) Injection
July 5, 2007 - Audience: Infectious disease specialists, hospital administrators and pharmacists, other healthcare professionals
Merck and FDA informed healthcare professionals that 3 lots of Invanz (0803930, 0803940, and 0803950), a product...

Rocephin (ceftriaxone sodium) for Injection
July 5, 2007 - Audience: Neonatologists, pediatricians, infectious disease specialists, hospital administrators, other healthcare professionals
Roche and FDA informed healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS,...

Colistimethate (marketed as Coly-Mycin M and generic products)
June 28, 2007 - Audience: Pulmonologists, respiratory therapists, compounding pharmacists, other healthcare professionals, cystic fibrosis patients
FDA notified healthcare professionals and cystic fibrosis patients that the Agency is...

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